Adenocarcinoma of the Prostate Clinical Trial
Official title:
A Phase 2 Study of Enzalutamide in Patients With High-risk Prostate Cancer Who Have Undergone Local Definitive Therapy With Radical Prostatectomy
The purpose of this study is to see how long it takes for prostate cancer to come back in
patients who have had surgery to remove their prostate gland (radical prostatectomy), while
being treated with enzalutamide (formerly known as MDV3100).
Enzalutamide is known as an androgen-receptor signaling inhibitor, which means that it blocks
activity of the male hormone, testosterone. Most prostate cancers are dependent on
testosterone for growth. In this study, patients will take enzalutamide after surgery to see
if it keeps their cancer from coming back.
This is a pilot phase II study evaluating the clinical activity and safety of Enzalutamide
(formerly known as MDV3100) a novel androgen receptor (AR) inhibitor in men with high-risk
prostate cancer who have undergone local definitive therapy with radical prostatectomy.
Primary Objectives:
-To evaluate the clinical efficacy of enzalutamide in patients with high-risk prostate cancer
with regards to: Time to disease progression defined by biochemical recurrence (BCR)
Secondary Objectives:
-To further evaluate the safety of enzalutamide in patients with high-risk prostate cancer
Patients will receive daily oral therapy with enzalutamide at 160mg (4 capsules) orally once
daily (QD). Patients will continue on study until progressive disease, drug intolerability,
consent withdrawal or completion of study at 24 months.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02217709 -
Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer
|
Phase 2 | |
| Completed |
NCT03077659 -
Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03624660 -
Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer
|
N/A | |
| Completed |
NCT01054079 -
Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
|
Phase 2 | |
| Terminated |
NCT00512668 -
Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer
|
Phase 1 | |
| Completed |
NCT00087139 -
Ixabepilone in Treating Patients With Metastatic Prostate Cancer
|
Phase 2 | |
| Completed |
NCT00182052 -
Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT03511196 -
Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer
|
Early Phase 1 | |
| Active, not recruiting |
NCT01655836 -
High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
|
Phase 1 | |
| Terminated |
NCT03535675 -
Muscadine Plus (MPX) In Men With Prostate Cancer
|
Phase 3 | |
| Terminated |
NCT01866423 -
Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
|
Phase 2 | |
| Completed |
NCT02234921 -
Pilot Study of DRibble Vaccine for Prostate Cancer Patients
|
Phase 1 | |
| Completed |
NCT01468532 -
Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03686683 -
Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT03689699 -
Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04694924 -
Prospective Prostate Cancer and Patient-reported Outcomes Registry
|
||
| Active, not recruiting |
NCT04909294 -
Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma
|
N/A | |
| Completed |
NCT02225925 -
Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound
|
N/A | |
| Completed |
NCT01949519 -
Docetaxel and Lycopene in Metastatic Prostate Cancer
|
Phase 1 | |
| Completed |
NCT01433913 -
Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
|
Phase 2 |